Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202211513812190 Date of Registration: 28/11/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title CHLORHEXIDINE MOUTHWASH TO REDUCE RESPIRTAORY TRACT INFECTIONS AFTER ABDOMINAL SURGERIES
Official scientific title RANDOMIZED PLACEBO-CONTROLLED TRIAL TESTING 0.2% CHLORHEXIDINE MOUTHWASH TO REDUCE POSTOPERATIVE RESPIRATORY TRACT INFECTIONS IN ABDOMINAL SURGERIES
Brief summary describing the background and objectives of the trial Postoperative respiratory tract infections are health care-associated infections that frequently complicate abdominal surgeries leading to significant morbidity and mortality. They account for about 25% of all deaths after surgery, second to surgical site infections which cause one-third of postoperative mortalities and 8% of all deaths due to health care-associated infections. Postoperative respiratory tract infections are particularly important in patients who have undergone high risk open abdominal surgeries as they significantly contribute to adverse outcomes such as deaths, prolonged hospital stay and increased health care costs. Respiratory tract infections after surgery may result from colonization and subsequent inflammation of the respiratory tract by bacteria which have colonized the oral mucosa. When general anaesthesia is being given, oropharyngeal secretions containing bacteria could be aspirated when the endotracheal tube is being passed. This potential source of infection can be curtailed by treating the oral cavity with antiseptic agent such as chlorhexidine gluconate mouthwash that reduce the population of bacteria in the mouth. Chlorhexidine gluconate mouthwash is being used in dental practice for this purpose to treat dental infections and have been used in critical care settings to reduce the rate of ventilated associated pneumonia after cardiac surgeries. However, there is paucity of data regarding the use of this agent in perioperative states for abdominal surgeries and in sub-saharan countries like Ghana. The aim of this study/trial is therefore to determine whether perioperative use of 0.2% chlorhexidine mouth wash reduces the rate of postoperative respiratory tract infections in 30 days postoperative period compared to standard practice. Secondary objectives will include determining the effect of this application on mortality rates and length of hospital stay after abdominal surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ROBOCOW
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/12/2022
Actual trial start date
Anticipated date of last follow up 30/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 104
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL Not yet published
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group chlorhexine gluconate mouthwash 15-20ml oral rinse stat single dose The stated dose of the chlorhexidine mouthwash will be administered to the patient who will rinse their mouth with the intervention. The agent will be kept in the mouth for at least one minute before the patient spits it out. It will be done once, and the patient will not be made to repeat the medication thereafter. 52
Control Group distilled water 15-20ml oral rinse stat single dose only The stated dose of the distilled water will be administered to the patient who will rinse their mouth with this intervention. The agent will be kept in the mouth for at least one minute before the patient spits it out. It will be done once, and the patient will not be made to repeat the agent thereafter. 52 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Participants who are 10 years and above 2. Participants presenting with either elective or emergency abdominal condition requiring midline laparotomy under general anaesthesia 3. Midline incision of at least 5cm long or more 4. Participants who have given written informed consent and/or assent 1. Non-midline abdominal incision 2. Emergency laparotomy for gynaecological conditions including caesarean sections 3. Patients who have documented allergy or hypersensitivity to chlorhexidine 4. Patients with documented evidence of pneumonia before surgery 5. Incisions less than 5cm 6. Those unable to complete follow up after surgery 7. Patients assessed to have ASA grade V, expected to die with or without surgery, before the commencement of surgery 8. Patients who have had abdominal surgery in another facility and referred to TTH for further management 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 10 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/08/2022 TAMALE TEACHING HOSPITAL ETHICAL REVIEW COMMITTEE
Ethics Committee Address
Street address City Postal code Country
P.O.BOX TL 16 TAMALE N/A Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome mortality from day of surgery up to 30 days after surgery
Primary Outcome respiratory tract infection from day of surgery up to 30 days after surgery
Secondary Outcome length of hospital stay from day of surgery up to 30 days after surgery
Secondary Outcome return to normal activity from day of surgery up to 30 days after surgery
Secondary Outcome unplanned readmission due to a respiratory complication day of surgery up to 30 days after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
TAMALE TEACHING HOSPITAL P.O.BOX TL16 TAMALE N/A Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Mohammed Sheriff Tamale Teaching Hospital, Box TL16 Tamale N/A Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor TAMALE TEACHING HOSPITAL P.O.BOX TL 16 TAMALE N/A Ghana Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MOHAMMED SHERIFF drsheriffmed@gmail.com +233208936509 TAMALE TEACHING HOSPITAL, P. O. BOX TL 16
City Postal code Country Position/Affiliation
TAMALE N/A Ghana SPECIALIST
Role Name Email Phone Street address
Public Enquiries SHAMUDEEN MOHAMMED ALHASSAN mohammed.shamudeen-alhassan@tth.gov.gh +233372000180 TAMALE TEACHING HOSPITAL, P.O.BOX TL 16
City Postal code Country Position/Affiliation
TAMALE N/A Ghana DEPUTY DIRECTOR AND HEAD OF RESEARCH AND DEVELOPMENT TTH
Role Name Email Phone Street address
Scientific Enquiries MOHAMMED SHERIFF drsheriffmed@gmail.com +233208936509 TAMALE TEACHING HOSPITAL, P.O.BOX TL 16
City Postal code Country Position/Affiliation
TAMALE N/A Ghana SPECIALIST
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes There is intent to make IPD available Clinical Study Report,Statistical Analysis Plan,Study Protocol Starting from three months and ending at five years from the date the article is published Data could be accessed by contacting the Research and Development office of the Tamale Teaching Hospital through the head of research- alhassan.shamudeen@tth.gov.gh Those who request data may be asked to sign a data access agreement to gain access to the data. Data may be given to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose to achieve specific aims in their protocol or to conduct meta-analyses. Additional information will be available on the institution's website at the URL below.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://www.tth.gov.gh/?page_id=419 No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information